- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02051738
A Study to Assess the Effect of Food on the Bioavailability of Mebendazole From a Fast-Disintegrating Chewable Formulation of Mebendazole in Healthy Participants
June 26, 2014 updated by: Janssen Research & Development, LLC
A Single-Dose, Open-Label, Randomized, 2-Way Crossover Study to Assess the Effect of Food on the Bioavailability of Mebendazole From a Fast-Disintegrating Chewable Formulation of Mebendazole in Healthy Subjects
The purpose of the study is to evaluate the effect of food on the bioavailability (how much medication is in your blood) of mebendazole from a single 500 mg oral dose of a fast-disintegrating chewable tablet formulation of mebendazole in healthy adult participants.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is an open-label (the participant and the study physician know what the participant is getting), randomized (like the flip of a coin), single-center, single-dose, 2-way crossover (method used to switch participants from one treatment arm to another in a clinical study) study in approximately 16 healthy adult participants.
Participants will receive study medication under fed state first and later under fasted state or vice versa.
The study consists of 3 phases: screening phase of approximately 3 weeks, an open-label treatment phase consisting of two 6-day treatment periods (Treatment period 1 and 2) with a 7- to 10 day washout between Day 1 of each treatment period, and a safety follow-up phase occurring 7 to 10 days after the last study-related procedure on Day 5 of Treatment Period 2. The study physician will check participant's general health during the study.
Total duration of study for each participant will be approximately 48 days.
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Merksem, Belgium
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 53 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Must have signed an informed consent document
- Woman must be postmenopausal, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry and throughout the study
- Woman must have a negative serum human chorionic gonadotropin pregnancy test at screening; and a negative urine pregnancy test on Day -1 of each treatment period
- Man must agree to use an adequate contraception method as deemed appropriate by the investigator and to not donate sperm during the study and for 3 months after receiving the last dose of study medication
- Blood pressure (after the participant is sitting for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
Exclusion Criteria:
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results
- Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or at admission to the study center on Day -1 of each Treatment Period as deemed appropriate by the investigator
- Clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram at screening or at admission to the study center on Day -1 of each Treatment Period as deemed appropriate by the investigator
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol, oral contraceptives and hormonal replacement therapy within 14 days before dosing in each treatment period
- Positive test for drugs of abuse, such as cannabinoids, alcohol, opiates, cocaine, amphetamines, benzodiazepines, hallucinogens or barbiturates at screening and Day 1 of the each treatment period
- History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Sequence AB
A single 500 mg dose of mebendazole fast-disintegrating chewable tablet will be administrated under fasted condition (Treatment A) in Treatment Period 1; In Treatment Period 2, the same medication will be administrated under fed condition (Treatment B).
|
Participants will receive a single 500 mg dose of mebendazole fast-disintegrating chewable tablet in the fasted condition.
Other Names:
Participants will receive a single 500 mg dose of mebendazole fast-disintegrating chewable tablet in the fed condition.
Other Names:
|
Experimental: Treatment Sequence BA
A single 500 mg dose of mebendazole fast-disintegrating chewable tablet will be administrated under fed condition (Treatment B) in Treatment Period 1; In Treatment Period 2, the same medication will be administrated under fasted condition (Treatment A).
|
Participants will receive a single 500 mg dose of mebendazole fast-disintegrating chewable tablet in the fasted condition.
Other Names:
Participants will receive a single 500 mg dose of mebendazole fast-disintegrating chewable tablet in the fed condition.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Concentration of mebendazole in blood and urine under fed and fasted condition
Time Frame: Up to Day 5 of in each treatment period
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Up to Day 5 of in each treatment period
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with adverse events
Time Frame: From screening up to 7 to 10 days after Day 5 of Treatment Period 2
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From screening up to 7 to 10 days after Day 5 of Treatment Period 2
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
January 30, 2014
First Submitted That Met QC Criteria
January 30, 2014
First Posted (Estimate)
January 31, 2014
Study Record Updates
Last Update Posted (Estimate)
June 27, 2014
Last Update Submitted That Met QC Criteria
June 26, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR103571
- MEBENDAZOLGAI1002 (Other Identifier: Janssen Research & Development, LLC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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